FDA WARNING_LETTER - Hyaluron Pen Store, LLC dba Glow Nest Beauty - March 03, 2025

On March 3, 2025, the FDA issued a Warning Letter to Glow Nest Beauty (Shabdan Akylbekov) regarding injectable lipolytic products sold on their websites, https://www.glownestbeauty.com/ and https://www.hyaworld.store/, and promoted on social media (Facebook: https://www.facebook.com/hyaluronpenoriginal/, Instagram: https://www.instagram.com/glownestbeauty/).

The FDA identified "PineBottle," "Super V-Line Sol," "LipoLab PPC Solution (brown bottle)," and "Deolipo" as unapproved new drugs. These products are considered drugs under section 201(g)(1) of the FD&C Act due to claims observed on their websites and social media, indicating intent to prevent, treat, or cure disease conditions and/or affect the body's structure or function. Examples of claims include "Enhance Skin Elasticity, Reduce Wrinkles," "Removes fat deposits and lifts the skin simultaneously," "fast subcutaneous fat removal," and "Completely removes excess fat without the need for any operations."

The FDA states these products are not generally recognized as safe and effective for their intended uses, classifying them as "new drugs" under section 201(p) of the FD&C Act. Their introduction into interstate commerce without an approved FDA application violates sections 505(a) and